Prognosis and Course of COVID-19 Infection in Hospitalised Patients

• Sponsor: I.M. Sechenov First Moscow State Medical University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04752085
• Collaborator: (none)
• Enrollment: 345
• Locations: 2
• Anticipated Duration (Months): 31.9
• Patients Per Site: 172.5
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients.

The investigators plan to include 300 patients hospitalised with COVID-19 infection.

The phone contacts with patients are due after 90 and 180 days after discharge.

Condition or Disease	Intervention/Treatment	Phase
Covid19; SARS-CoV Infection	Diagnostic Test: Chitotriosidase activity

Study Design

• Study Type: Observational
• Actual Enrollment: 345 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prognosis and Course of COVID-19 Infection in Hospitalised Patients
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. Need in biological therapy or/and respiratory support [Up to 1 month]

   The primary endpoint is the need in biological therapy or/and respiratory support including NIV during hospital stay

Secondary Outcome Measures

1. Number of days spent in hospital [Up to 1 month]

   The investigators plan to assess the overall length of hospitalisation due to COVID-19 infection as an outcome measure

2. All-cause death [90 days]

   To assess the all-cause death 90 days after discharge

3. All-cause death [180 days]

   To assess the all-cause death 180 days after discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hospitalisation with COVID-19

Exclusion Criteria:

• History of hospitalisation with COVID-19 infection

• Discharge from the hospital before the end of the treatment course

• Transfer to another hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital #1	Moscow		Russian Federation
2	University Hospital #4	Moscow		Russian Federation

Sponsors and Collaborators

• I.M. Sechenov First Moscow State Medical University

Investigators

• Principal Investigator: Olga Mironova, PhD, Sechenov University
• Study Chair: Ekaterina Schelkanovtseva, MD, Sechenov University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Chitotriosidase Activity in Lung Injury Associated with Coronavirus Disease 2019 (COVID-19)

Publications

None provided.

• Responsible Party: Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University
• ClinicalTrials.gov Identifier: NCT04752085
• Other Study ID Numbers: 03-21
• First Posted: Feb 12, 2021
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University: COVID-19; chitotriosidase; SARS-CoV Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Jan 4, 2022